Fujino, Akihiro
Fuchimoto, Yasushi
Mori, Teizaburo
Kano, Motohiro
Yamada, Yohei
Ohno, Michinobu
Baba, Yoshiyuki
Isogawa, Nobutaka
Arai, Katsuhiro
Yoshioka, Takako
Abe, Makoto
Kanai, Nobuo
Takagi, Ryo
Maeda, Masanori
Umezawa, Akihiro
Clinical trials referenced in this document:
Documents that mention this clinical trial
Evaluation of safety and efficacy of autologous oral mucosa-derived epithelial cell sheet transplantation for prevention of anastomotic restenosis in congenital esophageal atresia and congenital esophageal stenosis
https://doi.org/10.1186/s13287-023-03321-8
Funding for this research was provided by:
AMED (JP18bk0104006, JP22bk0104140)
Article History
Received: 6 November 2022
Accepted: 29 March 2023
First Online: 13 April 2023
Declarations
:
: The entire study including the clinical intervention component and experiments with human cells and tissues, was approved by the Institutional Review Board and Certified Special Committee for Regenerative Medicine at the National Center for Child Health and Development (project title: Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia, approval number: 1202, date of approval: December 17th, 2018). Human cells in this study were utilized in full compliance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects (Ministry of Health, Labor, and Welfare (MHLW), Japan; Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japan). Consent to participate in this study was obtained from the parents of subject 1 and subject 3 and from subject 2 himself and his parents.
: Consent for publication was obtained from the parents of subject 1 and subject 3 and from subject 2 himself and his parents.
: AU is a co-researcher with CellSeed Inc. MM is the CEO of MakeWay LLC. The other authors have no conflicts of interest regarding the work described herein. AU is the associate editor of the journal and was not involved in the peer review process of the article.